Silver Diamine Fluoride Pilot Study (SDF) (SDF)

• ClinicalTrials.gov Identifier: NCT02591147
• Recruitment Status: Active, not recruiting
• First Posted: October 29, 2015
• Last Update Posted: December 28, 2021
• Sponsor: Justine Kolker
• Information provided by (Responsible Party): Justine Kolker, University of Iowa

Study Description

Brief Summary:

This pilot trial is randomized, double-blind, and placebo-controlled trial with two parallel arms: an intervention group using silver diamine fluoride (SDF) and a placebo group (control). 60 eligible healthy adults will be enrolled in the study and randomly assigned to one of the two treatment groups. Both groups will receive the traditional preventive measures including cleanings, Fluoride varnish, diet analysis and counseling. Study participants will be followed for one year and caries progression will be radiographically monitored.

Condition or disease	Intervention/treatment	Phase
Dental Caries	Device: Silver Diamine Fluoride 38%; Device: Group 2 (Placebo)	Not Applicable

Detailed Description:

This pilot study will compare 1) Silver diamine fluoride (SDF) and fluoride varnish to 2) Placebo and fluoride varnish (conventional prevention) in the management of early approximal carious lesions. Early approximal carious lesions refers to decay between teeth, diagnosed with radiographs, not extending more than 1/3 of the way into dentin. Management of early approximal carious lesions refers to halting lesion progression, or encouraging lesion reversal after an early carious lesion is detected.

SDF provides a novel, low-cost intervention option for managing early carious lesions that could potentially bridge the 'gap' between non-operative and operative options; thus, postponing the first placement of a restoration. SDF has been used in arresting carious lesions for more than 100 years. However, SDF has never been tested in the arrest of approximal caries lesions in permanent teeth.

SDF acts to both prevent and arrest tooth decay in multiple ways: 1) it acts on the body of carious lesions by precipitating silver ion into the lesion, thus blocking diffusion pathways for cariogenic acids; 2) it interacts with dental enamel leading to the formation of fluoroapatite crystals making the tooth surface more acid resistant; and 3) the precipitated silver from SDF acts as a bactericidal agent disturbing the formation of cariogenic biofilm.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Health Services Research
• Official Title: Effectiveness of Silver Diamine Fluoride in Arresting Early Approximal Carious Lesion Progression: A Pilot Study
• Actual Study Start Date: January 7, 2016
• Actual Primary Completion Date: August 1, 2021
• Estimated Study Completion Date: June 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Silver Diamine Fluoride 38%; Group 1 (SDF 38%) will receive the application of silver diammine fluoride (38% SDF solution) in addition to 5% sodium fluoride varnish to each approximal carious lesion (scores RA1,RA2,RA3) in a posterior tooth (premolar or molar) that is in contact with an adjacent tooth, using super floss, for a duration of 3 minutes under rubber dam isolation.	Device: Silver Diamine Fluoride 38%; Group 1 (SDF group) subjects will receive the application of silver diamine fluoride (38% SDF solution) in addition to 5% Fluoride varnish to each approximal incipiency, using super floss, for a duration of 3 minutes under rubber dam isolation.; Other Name: 38% SDF
Placebo Comparator: Placebo (Sterile water); Group 2 Placebo (control) will receive the application of sterile water (placebo) in addition to 5% sodium fluoride varnish to each approximal carious lesion (scores RA1,RA2,RA3) in a posterior tooth (premolar or molar) that is in contact with an adjacent tooth, using super floss, for a duration of 3 minutes under rubber dam isolation.	Device: Group 2 (Placebo); Group 2 (Placebo) subjects will receive application of sterile water (placebo) in addition to 5% Fluoride varnish to each approximal incipiency, using super floss, for a duration of 3 minutes under rubber dam isolation.; Other Name: Sterile Water

Outcome Measures

Primary Outcome Measures :

1. Caries Progression [ Time Frame: 12 months ]
   comparison of radiographs to determine if there is caries progression in the subjects approximal lesions based on the radiographic examination.

Secondary Outcome Measures :

1. Incidence of caries in all other teeth in the study subject [ Time Frame: 12 months ]
   Count for new carious lesions developing over the course of the study period to assess the effect of SDF on preventing the development of early carious lesions

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 64 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Presence of at least one approximal caries lesion (scores RA1, RA2, RA3 according to the ICCMS radiographic scoring system) in one of the posterior teeth (premolars and molars) presented with full contact with the adjacent tooth.
• All the surfaces eligible for this study will be included.

Exclusion Criteria:

• The approximal lesion detected in the radiograph has advanced dentine lesion (RB4, RC5, or RC6)
• or is adjacent to a lesion that is either filled or will receive a filling at the time of enrollment.

Contacts and Locations

Locations

United States, Iowa

University of Iowa

Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

Justine Kolker

Investigators

• Principal Investigator: Michael Kanellis, DDS, MS; University of Iowa
• Principal Investigator: Justine Kolker, DDS, MS; University of Iowa

More Information

Publications:

Rosenblatt A, Stamford TC, Niederman R. Silver diamine fluoride: a caries "silver-fluoride bullet". J Dent Res. 2009 Feb;88(2):116-25. doi: 10.1177/0022034508329406. Review.

Santos VE Jr, Vasconcelos Filho A, Targino AG, Flores MA, Galembeck A, Caldas AF Jr, Rosenblatt A. A new "silver-bullet" to treat caries in children--nano silver fluoride: a randomised clinical trial. J Dent. 2014 Aug;42(8):945-51. doi: 10.1016/j.jdent.2014.05.017. Epub 2014 Jun 12.

Peng JJ, Botelho MG, Matinlinna JP. Silver compounds used in dentistry for caries management: a review. J Dent. 2012 Jul;40(7):531-41. doi: 10.1016/j.jdent.2012.03.009. Epub 2012 Apr 3. Review.

Mattos-Silveira J, Floriano I, Ferreira FR, Viganó ME, Frizzo MA, Reyes A, Novaes TF, Moriyama CM, Raggio DP, Imparato JC, Mendes FM, Braga MM. New proposal of silver diamine fluoride use in arresting approximal caries: study protocol for a randomized controlled trial. Trials. 2014 Nov 19;15:448. doi: 10.1186/1745-6215-15-448.

Tellez M, Gomez J, Kaur S, Pretty IA, Ellwood R, Ismail AI. Non-surgical management methods of noncavitated carious lesions. Community Dent Oral Epidemiol. 2013 Feb;41(1):79-96. doi: 10.1111/cdoe.12028. Review.

Llodra JC, Rodriguez A, Ferrer B, Menardia V, Ramos T, Morato M. Efficacy of silver diamine fluoride for caries reduction in primary teeth and first permanent molars of schoolchildren: 36-month clinical trial. J Dent Res. 2005 Aug;84(8):721-4.

Ekstrand KR, Bruun G, Bruun M. Plaque and gingival status as indicators for caries progression on approximal surfaces. Caries Res. 1998;32(1):41-5.

• Responsible Party: Justine Kolker, Principal Investigator, University of Iowa
• ClinicalTrials.gov Identifier: NCT02591147
• Other Study ID Numbers: 201509831
• First Posted: October 29, 2015
• Last Update Posted: December 28, 2021
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Fluorides; Cariostatic Agents; Protective Agents; Physiological Effects of Drugs